The 340B Mega-Reg Is Dead

From: Mondaq

Article by Ellyn L. Sternfield | Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.”  And to quote one of my favorite sports commentators, Tony Kornheiser, “I believe I had that.”

Paperwork Reduction(?) Act

Editor’s Note: For information on the purpose and value of the PRA process, see here. For Commissioner Clyburn’s remarks on the FCC being hampered by adherence to OMB’s PRA requirements, see here.

From: CommLawBlog

A recent notice about DTV construction permit applications got us thinking about our old friend, the PRA.

Has the FCC changed the process for applying for DTV construction permits? Probably not, but a recent notice in the Federal Register seemed to suggest otherwise. It turns out, though, that the real story here is the hypnotic effect of the Paperwork Reduction Act (PRA).

State Farm ‘with Teeth’: Heightened Judicial Review in the Absence of Executive Oversight

Editor’s Note: An interview with Professor Sharkey about the forthcoming paper is available here.

From: New York University Law Review, Vol. 89, 2014/NYU School of Law, Public Law Research Paper No. 14-15

Catherine M. Sharkey,New York University School of Law


Book Review: Valuing Life: Humanizing the Regulatory State by Cass Sunstein

From: The London School of Economics and Political Science/Review of Books

In Valuing Life, Cass Sunstein surveys a wide range of practical research and real-life policymaking in his characteristically lucid style, offering a candid and humble account of his administrative tenure in Washington. He performs an invaluable service in revealing how government regulators balance pragmatic concerns of resource scarcity with principled ideals of respect and dignity, writes Mark D. White.

Regulating through the Back Door at the Commodity Futures Trading Commission

Editor’s Note: The solution to backdoor regulation is the Data Quality Act.

From: Mercatus Center/George Mason University

Hester Peirce

The traditional method of regulating under the Administrative Procedure Act (APA)—the law that governs regulatory agency rulemaking—requires a notice-and-comment process, where the regulating agency informs the public of its proposed rule, seeks feedback from the public and interested parties, and performs a benefit-cost analysis of the proposed rule. These requirements boost public confidence in the regulatory process and allow regulated businesses to prepare for and understand new rules, which leads to better compliance.

A Closer Look: The [PA] Independent Regulatory Review Commission, with Chairman John Mizner

From: The PLS Reporter

Author: Josh Levy

“People don’t know that we actually do have a review process here in Pennsylvania that is unique among the 50 states, and there is no such thing in the federal government,” John Mizner, Esq., chairman of the Independent Regulatory Review Commission, told The PLS Reporter.

“We’re the most important commission in Harrisburg that no one has ever heard of,” Mizner remarked, even though “virtually everybody” is affected in some way by the regulations approved by the commission.


Supreme Court Regulatory Cases to Watch

Editor’s Note: An influential regulatory case to watch is Harkonen v. U.S. Dept. of Justice (No. 13-15197). CRE’s amicus brief is found at

From: RegBlog/Penn Program on Regulation

A Facebook rapper, a bearded prisoner, and a red grouper fisherman will all figure into a highly anticipated Supreme Court term that includes several cases that may affect the American regulatory landscape.


Department of Energy Rules Take Longest For White House to Review, Data Indicate

Editor’s Note: For more information on OIRA participation in agency rulemaking, please see Proper and Desirable Intervention by the President in Agency Rulemaking.

From: BNA/Bloomberg | Daily Environment Report™

By Ari Natter

The White House Office of Management and Budget takes more than five months on average to review regulations crafted by the Energy Department, making the department’s rules the most delayed of all federal agencies, according to a Bloomberg BNA analysis of agency data.